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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Granuloma (1876); Impaired Healing (2378); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Sent to the fda. (b)(4). Attempts to obtain the following information have been made, no response has been received to date. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon products (prineo, stratafix suture and monocryl suture) involved caused and/or contributed to the post-operative complications described in the article? what was the indication of dog-ear corrections? were these related to the sutures used in wound closure such as monocryl sutures and stratafix sutures? which group did the minor granuloma occur? does the surgeon believe there was any deficiency with the ethicon products (prineo, stratafix suture and monocryl suture) used in this procedure? (b)(4).
 
Event Description
Title : a comparative trial of incisional negative-pressure wound therapy in abdominoplasty. Author : gerald m. Abesamis, md, shiv chopra, mbbs, bsc, mrcs, karen vickery, bvsc, phd, anand k. Deva, bsc , mbbs, ms, fracs. Citation: plast reconstr surg glob open 2019;7:e2141; doi: 10. 1097/gox. 0000000000002141. This prospective consecutive cohort study aimed to determine whether the use of incisional negative-pressure wound therapy (inpwt) dressing in patients undergoing an abdominoplasty can reduce postoperative drainage output and adverse events compared to standard postoperative dressings. A total of 16 female patients who underwent abdominoplasty were divided into two groups based on the dressing technique: control group which utilized standard dressings (n
=
7; mean age of 49 years [ranged 33-61 years]; mean average body mass index of 35. 36kg/m^2 [ranged 23. 7-57. 9 kg/m^2]) and treatment group which utilized inpwt (n
=
9; mean age of 41 years; average bmi of 29. 94 kg/m^2 [ranged 25. 4-37. 1 kg/m^2]). In the procedure, standard layered closure of the scarpa¿s and skin layers was done using 3-0 and 4-0 resorbable monofilament sutures (monocryl and stratafix, ethicon) on both groups. In the control group, skin was dressed with adhesive and tapes (prineo); while inpwt prevena system was utilized in the treatment group. Complications included hypertrophic scars (n
=
1) which underwent subsequent steroid/laser therapy; 3 patients requiring dog-ear corrections at the 6-month mark; and a minor granuloma and delayed wound healing of umbilicus (n
=
1) which resolved with topical silver treatment within 2 weeks. Surgical strategies that reduce drainage in abdominoplasty also include using progressive tension sutures and tissue adhesives. The findings showed that inpwt for a closed abdominoplasty incision decreases the rate of postoperative fluid accumulation and results in earlier drain removal.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9484692
MDR Text Key188032342
Report Number2210968-2019-91017
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2019 Patient Sequence Number: 1
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